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Postanalytic Risk Reduction
in Pathology Results Reporting
Session 281, February 14, 2019
Mahmoud A. Khalifa, MD, PhD,
Professor, University of Minnesota
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Mahmoud A. Khalifa, MD, PhD
Has no real or apparent conflicts of interest to report.
Conflict of Interest
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Real-life example of a laboratory error
The various phases of a laboratory test
Existing challenges in results reporting
Proposed strategies for risk reduction with examples of quality
improvement projects
Discrete date formatting for diagnostic elements
College of American Pathologists cancer checklists
Real-time reporting of intraoperative consultation
Question and answers (discussion)
Agenda
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Identify existing gaps in medical records information systems that
could potentially cause patient harm
Recognize the human factor role with real-life examples of
laboratory results reporting errors and its mitigation through LIS
innovations
Compare EHR-integrated and stand alone Laboratory Information
Systems in their abilities to mitigate postanalytic reporting errors
Define the role of healthcare champions in innovation beyond the
existing systems to develop customized patient safety solutions
Work with home institutions on the development and adoption of
patient safety initiatives focusing on closing the gaps in laboratory
results reporting
Learning Objectives
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Mrs. O is an 81 year old female with a 3 year past history of breast
cancer. She presented with a one year history of pain in her right
leg and a recent right femur fracture. A biopsy was obtained
during surgical correction of the fracture.
Pathology diagnosis: Metastatic carcinoma.
Pathology comment: Malignant cells are strongly positive for
CK7. ER, GCDFP, CK20, TTF1 and CDX2 are negative. These
results are non-specific with markers for breast, lung, colon all
being negative
Mrs. O
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Newly diagnosed metastatic cancer in right femur.
Cancer cells are ER strongly positive
It seems like it is a relatively indolent ER-positive metastatic
breast cancer.
Targeted therapy ± antitumoral therapy for breast cancer is her
first option.
Clinical notes Assessment and Plan
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Mrs. O is an 81 year old female with a 3 year past history of breast
cancer. She presented with a one year history of pain in her right
leg and a recent right femur fracture. A biopsy was obtained
during surgical correction of the fracture.
Pathology diagnosis: Metastatic carcinoma.
Pathology comment: Malignant cells are strongly positive for
CK7. ER, GCDFP, CK20, TTF1 and CDX2 are negative. These
results are non-specific with markers for breast, lung, colon all
being negative
Mrs. O
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The clinical care Pathology circle
Operating Room Histology Lab
Pathologist
Specimen Slide
Healthcare team
Treatment
Start/End
Report
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A chain is as strong as
its weakest link
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The clinical care Pathology circle
Operating Room Histology Lab
Pathologist
Specimen Slide
Healthcare team
Treatment
Start/End
Report
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Phases of the laboratory test cycle
Pre-
analytic
Analytic
Post-
analytic
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The shift with time
Pre-
analytic
Analytic
Post-
analytic
Past Present Future
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Patient chart The 20
th
century model
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Emergence of large healthcare systems
in the 21
st
century
Large healthcare systems with multi-billion $$ budgets
dominate the healthcare industry
Progressive shift to organization-wide Electronic Health
Records (EHR) to serve their multi-site operations
Pathology informaticians are carved out of the labs and
are embedded in these large systems
Expectedly, a corporate culture dominated laboratory
informatics
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Laboratory Information System (LIS)
Stand alone
EHR-based
EHR
LIS
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EHR LIS communication
Test
order
Report
Test
order
Patient chart
Authorizing provider
Procedure (encounter) provider
Mutidisciplinary providers
Future/scheduled providers
Splitting samples
Referring provider (another
institution)
Second opinion, external provider
Patients movement
Addendum
Amendment
Molecular
Send out
Arch Pathol Lab Med 2015;139:319-327
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Order-entry and results-reporting
interface in a large tertiary care
system
1. Ambulatory clinic: Authorizing provider
2. Hospitalized patients:
A. Patient still in hospital: Authorizing provider + Current
attending
B. Patient discharged: Authorized provider + Last attending
3. ED: Authorized provider + ED queue
4. Resident clinics: Residents + Attending + Scheduled
encounter provider + Nurse pool
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Challenges in large healthcare systems
Integration of LIS and EHR (stand-alone versus
integrated)
With IT centralization, labs lose control and influence for
decision making and prioritization
LIS capital is in competition with other enterprise-wide IT
projects prioritization is balanced by resources required
for maintenance of older systems
Effective communication with providers outside the
LIS/EHR
Efficient and effective reporting special challenges of
precision medicine
Arch Pathol Lab Med 2015;139:311-318
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The long road ahead
Closing the loop: Importing diagnostic
elements directly into clinical notes and
treatment plans
Standardized terminology
How to deal with uncertainty?
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Closing the loop
Treatment
plan
Clinical
notes
Pathology
Report
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Discrete data formatting of diagnostic
elements
Treatment
plan
Clinical
notes
Pathology
Report
Storing diagnostic elements as discrete data enable
exporting to other medical records, eliminating the
human factor
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College of American Pathologists (CAP) Cancer protocols
Synoptic reporting Choose from a drop-down menu
Some customization is allowed (rather limited)
It is now the standard of practice for CAP accreditation
Use of standardized terminology
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Communicating uncertainty
(Heavy reliance on the comment section)
Reporting immunohistochemistry is the most problematic
Some providers claimed they ALWAYS read the comment while
others admitted they don’t
Varying confidence
Inconsistent use of phrases
Academic Pathology 2016;3:1-7
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Intraoperative consultation (IOC) by
pathologists
Preliminary
diagnosis
under 20
minutes
Verbally, by phone
or intercom
Immediate next step
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In most pathology departments IOC is communicated to surgeons
who would later enter their impressions in their operative notes
In October 2016, our department started a new workflow for real-
time reporting of IOC from our stand alone LIS in the EHR
Two years later, we assessed the benefits of this strategy
It is of note that this workflow is built in EHR-integrated systems
Metrics investigated:
Utility of this approach to the clinical team
Its impact on reducing errors
Real-time reporting of intraoperative
consultation (IOC) in EHR
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We extracted data from our stand-alone LIS (2814 consecutive
patient encounters). We joined this list to our EHR database and
extracted corresponding audit regarding review of results in
medical records
We analyzed the data to determine if IOC results were reviewed
in the medical records during the period of time between the
release of the preliminary IOC result and the final report was filed
in the chart
Is it utilized by clinicians?
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Is it utilized by clinicians?
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We pulled consecutive cases and compared the IOC diagnosis
with the operative notes
Does it reduce errors?
Number of cases reviewed
Number of
discrepancies
150 before implementation
13
150 after implementation
year 1 6
150 after implementation
year 2 7
TOTAL
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It is built-in for EHR-integrated systems and can be developed in
stand-alone LIS
Clinicians use it heavily immediately after surgery (communicate
with patient, family, advise other team members of immediate
steps..)
Clinicians also use it around the time of release of final report to
correlate preliminary versus final results
It significantly reduces miscommunication between pathologists
and surgeons
Next step: If stored as a discrete data field, the intraoperative
diagnosis can be exported to the operative note
Real-time reporting of intraoperative
consultation (IOC) in EHR
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The current state of pathology result-reporting in the EHR era is
less than perfect since several communication/documentation
steps are done manually
Error-reduction strategies are currently implemented to improve
patient safety both in stand alone and EHR-integrated systems
Healthcare champions will need to continue to work with their
home institutions to develop and adopt patient safety initiative
In closing..
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Please, continue the discussion and I would like to hear
your thoughts and ideas
Mahmoud A. Khalifa, MD, PhD
Director, Anatomic Pathology
Professor, University of Minnesota
mkhalifa@umn.edu
Please, remember to complete online session evaluation
Questions